What the FDA's new ACE Pump indication means for people with diabetes, Tidepool, and Tidepool Loop

There’s a lot to celebrate and explain - here’s the short version:

1. This is really, really good. Way to go FDA and Tandem.
2. Two down, one to go. We're working on the iController piece, and we hope other companies are, too.
3. This will make things better for the community soon ONLY IF device companies step up soon, get business deals done, and submit their products. Device companies - it's your turn.
4. This is awesome, but don't lose sight of the ultimate goal: an interoperable, plug and play ecosystem where device companies openly publish their secure data and control protocol. We're not there yet, but it's still our vision.

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Yesterday the diabetes community celebrated a tremendous step forward in the name of patient choice in the form of a press release from the FDA, “FDA authorizes first interoperable insulin pump intended to allow patients to customize treatment through their individual diabetes management devices.” Specifically, Tandem Diabetes received the go-ahead from the FDA to market their t:slim X2 insulin pump as “interoperable” with a new “alternate controller enabled” (ACE) pump indication.

Here at Tidepool, we’re thrilled about this for a few reasons. First, this is a continued demonstration of the FDA making good on their vision of interoperability for diabetes devices, something they’ve been pushing for for years. Second, things are moving quickly, and that’s always a good sign. We’ve long believed the FDA is not the enemy. In fact, we know the FDA is a partner that wants to get better, safer, more effective digital health solutions to market as quickly as possible. This is why we engage with them early, engage often, and be as open and transparent as we can. Third, this is the next piece in the puzzle that leads all of us to interoperable, automated closed loop systems.

Breaking down iCGM and ACE pump

Last year, the FDA classified Dexcom’s G6 Continuous Glucose Monitor (CGM) as an integrated CGM, or iCGM. This did four things:

1. It allowed the G6 to integrate with other medical devices (see Tandem’s Basal-IQ)
2. It allows for the approval of future iCGMs to be considered as Class-II devices (whereas the CGM used to be a Class-III device).
3. It showed the path for other companies to receive the same classification. If you demonstrate you adhere to the iCGM special controls, congratulations, you have an iCGM that can also integrate with other devices.
4. It allowed other devices that receive iCGM classification to be swapped out interchangeably, and without needing to be re-approved by the FDA for every software update or hardware revision.

As an example of what this enables, presuming another iCGM comes to market and this company works together with Tandem, Basal-IQ could work with that brand new iCGM without a new FDA filing. Which means choice and innovation come to market faster, which is a huge win for the diabetes community!

Now, we have the ACE pump classification (what we affectionately called "iPump" before this announcement). Again, this sets the stage for companies to innovate in a few ways.

1. In this specific case, it allows the t:slim X2 to integrate with other controllers and CGMs. What that looks like is still TBD at this point, but it’s worth noting this is a separate path than their upcoming Control-IQ update, and will pave the way for more updates and innovation from Tandem.
2. It shows the path for other companies to receive the same ACE pump classification. Again, if you demonstrate that your device adheres to the ACE pump special controls, congratulations, your insulin pump is ready to integrate with other automated system components.
3. Once approved, any new technology that integrates with one ACE pump should be able to integrate with any ACE pump without an additional FDA filing. That doesn’t account for the work required to make these types of technologies work together, nor for getting the business deals between the companies done, when necessary, but the FDA will not be the barrier to making this happen. And that’s super important (in our humble opinion).

A practical example of interoperability

You buy a car that includes tires, windshield wipers, and a radio (among other things). If you want to use a different radio or different tires or different wipers, you can change your tires, or install a new radio, or buy new windshield wipers. You get to choose.

Now reread that sentence but replace “car” with “automated closed loop system”, “tires” with “pump”, “windshield wipers” with “CGM”, and “radio” with “closed loop app”. You still get to choose!

While this is a huge and necessary step forward, it's also important to remember that this will not YET create a truly interoperable plug and play ecosystem where people with diabetes can choose their own components, and they will just work. For now, component companies will still likely need to do business deals with each other to get access to device data protocols. That's a business decision, not a regulatory requirement. But the potential is there, and that’s what we’re keen on.

Completing the interoperability puzzle

The FDA has cleared the way for iCGM and ACE pumps, now we just need the iController to complete the interoperability puzzle. From our perspective, the FDA gets it. Their goal is to review interoperable components rather than monolithic closed loop systems. Now it’s up to the rest of us to make good on our contribution to this ambitious, but achievable goal of interoperability.

Ultimately, it’s about actions and deeds towards the open and interoperable future we so desperately want for us and our loved ones. Tandem and the FDA should be applauded for taking this next step towards an interoperable diabetes device ecosystem. We now have iCGM and ACE pumps. Yay! Now we just need an iController to complete the picture (of course we’re working on that ourselves, you can read more about that here and we hope others are as well), and of course we need many more companies to step up with their own iCGMs, ACE pumps, and iControllers.

Without an interoperable app controlling an ACE pump, powered by data from an iCGM, there is no interoperable automated closed loop system. What that final definition and special controls turn out to be could be the result of our own FDA filing - we’ve started that conversation with the FDA - or it could be from some other company. We’re not picky, we just want interoperability.

What this mean for Tidepool and Tidepool Loop

At the end of the day, this means two down and one to go.

Prior to these paths being available, for Tidepool Loop to support a new pump, a full, Class-III PMA submission would have been required with clinical trials providing additional supporting data that Loop works with the new system. That approach could take years. Assuming that Tidepool Loop had an iController indication, and iCGM and ACE pumps are available, the regulatory cost of adding an ACE designated pump will be very small.

We still envision a future where device companies openly publish their secure, authenticated control protocols, so that anyone can deliver components that will work with their device. This is our mission. This is our focus. This is the open, interoperable future we are working to deliver to people with diabetes.

As we have more updates to share on Tidepool Loop, you can find them at https://tidepool.org/loop.